FDA tso cai rau kev lag luam ntawm Cov Khoom Siv Hauv Qhov Ncauj Tshiab los ntawm Premarket Tobacco Product Application Pathway

Cov ntaub ntawv qhia cov tub ntxhais hluas, cov neeg tsis haus luam yeeb, thiab cov neeg haus luam yeeb yav dhau los tsis zoo li yuav pib lossis rov pib siv luam yeeb nrog cov khoom no

Niaj hnub no, US Food and Drug Administration tshaj tawm tias nws tau tso cai rau kev lag luam ntawm plaub lub qhov ncauj tshiab cov khoom lag luam uas tsim los ntawm US Smokeless Tobacco Company LLC raws li lub npe ntawm Verve.Raws li FDA qhov kev tshuaj xyuas tag nrho ntawm cov pov thawj kev tshawb fawb muaj nyob rau hauv lub tuam txhab cov khoom siv luam yeeb ua ntej (PMTAs), lub koom haum txiav txim siab tias kev lag luam ntawm cov khoom no yuav ua raws li txoj cai lij choj, "tsim nyog rau kev tiv thaiv pej xeem kev noj qab haus huv."Qhov no suav nrog kev tshuaj xyuas cov ntaub ntawv qhia tias cov tub ntxhais hluas, cov neeg tsis haus luam yeeb thiab cov neeg haus luam yeeb yav dhau los yuav tsis zoo li yuav pib lossis rov pib siv luam yeeb nrog cov khoom no.Cov khoom plaub yog: Verve Discs Blue Mint, Verve Discs Green Mint, Verve Chews Blue Mint, thiab Verve Chews Green Mint.

"Kev ua kom ntseeg tau cov khoom lag luam luam yeeb tshiab tau txais kev soj ntsuam ua ntej muag khoom zoo los ntawm FDA yog ib feem tseem ceeb ntawm peb lub luag haujlwm los tiv thaiv pej xeem - tshwj xeeb yog menyuam yaus.Thaum cov no yog mint flavored khoom, cov ntaub ntawv xa mus rau FDA qhia qhov kev pheej hmoo rau cov hluas uptake ntawm cov khoom tshwj xeeb no yog tsawg, thiab nruj kev lag luam kev txwv yuav pab tiv thaiv cov hluas raug, "said Mitch Zeller, JD, tus thawj coj ntawm FDA's Center for Tobacco Products. ."Qhov tseem ceeb, cov pov thawj qhia tau hais tias cov khoom no tuaj yeem pab cov neeg haus luam yeeb uas siv cov khoom siv hluav taws xob ntau tshaj plaws hloov mus rau cov khoom lag luam uas muaj cov tshuaj phem tsawg dua."

Cov khoom lag luam Verve yog cov khoom haus luam yeeb hauv qhov ncauj uas muaj nicotine muab tau los ntawm kev haus luam yeeb, tab sis lawv tsis muaj cov txiav, hauv av, hmoov los yog nplooj ntawv luam yeeb.Tag nrho plaub yam khoom yog chewed thiab muab pov tseg, es tsis nqos, thaum tus neeg siv khoom tiav lawm.Cov discs thiab chews txawv ib feem los ntawm lawv cov kev ntxhib los mos.Ob leeg yog hloov tau, tab sis cov discs yog ruaj, thiab cov chews yog mos.Cov khoom no yog npaj rau cov neeg laus haus luam yeeb.

Ua ntej tso cai cov khoom luam yeeb tshiab los ntawm txoj kev PMTA, FDA yuav tsum, raws li txoj cai, coj los txiav txim siab, ntawm lwm yam, qhov zoo li cov neeg siv luam yeeb tam sim no yuav tsum tsis txhob siv cov khoom luam yeeb thiab qhov tshwm sim uas cov neeg tsis siv tam sim no yuav pib siv cov khoom luam yeeb.Kev tshawb fawb qhia tau hais tias muaj feem tsawg uas cov tub ntxhais hluas, cov neeg tsis haus luam yeeb, lossis cov neeg haus luam yeeb yav dhau los yuav pib lossis rov pib haus luam yeeb nrog Verve cov khoom.Cov neeg siv tam sim no ntawm Verve cov khoom lag luam thiab cov neeg siv hloov pauv mus rau Verve cov khoom lag luam feem ntau raug cuam tshuam rau cov khoom tsim teeb meem tsawg dua thiab muaj peev xwm tsim teeb meem piv rau cov luam yeeb thiab lwm yam khoom haus luam yeeb.Lub koom haum tau tshaj tawm cov ntsiab lus txiav txim siab uas piav qhia ntxiv txog lub hauv paus rau kev tshaj tawm kev tshaj tawm kev lag luam rau plaub yam khoom no.

Cov ntawv tso cai ua lag luam uas tau tshaj tawm hnub no tso cai rau plaub yam khoom luam yeeb raug cai muag lossis xa tawm hauv Tebchaws Meskas, tab sis nws tsis txhais tau tias cov khoom muaj kev nyab xeeb lossis "FDA pom zoo," vim tias tsis muaj cov khoom lag luam luam yeeb.

Tsis tas li ntawd, FDA tau tso cov kev txwv nruj npaum li cas Verve cov khoom lag luam tau ua lag luam, suav nrog hauv cov vev xaib thiab los ntawm kev tshaj xov xwm platforms, los pab kom ntseeg tau tias kev lag luam cov hom phiaj tsuas yog cov neeg laus.FDA yuav soj ntsuam cov ntaub ntawv tshiab muaj txog cov khoom lag luam los ntawm cov ntaub ntawv tshaj tawm thiab cov ntawv ceeb toom uas xav tau hauv kev txiav txim lag luam.Lub tuam txhab yuav tsum tsis tu ncua qhia rau FDA nrog cov ntaub ntawv hais txog cov khoom lag luam, suav nrog, tab sis tsis txwv rau, txuas ntxiv thiab ua tiav cov kev tshawb fawb ntawm cov neeg siv khoom, kev tshaj tawm, kev npaj ua lag luam, cov ntaub ntawv muag khoom, cov ntaub ntawv ntawm cov neeg siv tam sim no thiab tshiab, kev tsim khoom hloov pauv. thiab tej yam tsis zoo.

FDA yuav thim daim ntawv xaj khoom lag luam yog tias nws txiav txim siab tias kev lag luam txuas ntxiv ntawm cov khoom lag luam tsis tsim nyog rau kev tiv thaiv kev noj qab haus huv rau pej xeem, piv txwv li, vim yog qhov tseem ceeb ntawm cov khoom lag luam los ntawm cov tub ntxhais hluas.

Lub koom haum txuas ntxiv ua kev tshuaj xyuas ua ntej ntawm ntau txhiab daim ntawv thov cov khoom lag luam luam yeeb thiab tseem cog lus rau kev sib txuas lus nrog cov pej xeem txog kev nce qib, suav nrog kev tshaj tawm kev lag luam tsis kam xaj rau ntau tshaj li ib lab cov khoom lag luam e-luam yeeb uas tsis muaj pov thawj txaus tias lawv muaj txiaj ntsig. rau cov neeg laus haus luam yeeb txaus los kov yeej cov kev txhawj xeeb ntawm pej xeem kev noj qab haus huv tshwm sim los ntawm cov ntaub ntawv zoo thiab muaj txiaj ntsig zoo ntawm cov khoom zoo li no rau cov hluas.